Scientific Publications by FDA Staff

Vox Sang 2020 May 28 [Epub ahead of print]

Use of COVID-19 convalescent plasma in low- and middle-income countries: a call for ethical principles and the assurance of quality and safety.

Epstein J, Smid M, Wendel S, Somuah D, Burnouf T

Most high-income countries are aggressively engaged in the collection and research evaluation of convalescent plasma as a specific passive immunotherapy for treatment of COVID-19. Preliminary clinical data fully support such initiatives. Outbreaks of COVID-19 are now dramatically affecting LMIC, which have restricted capability for ensuring organized and controlled collection of safe blood and plasma collection due to fragmented blood systems with limited oversight, infrastructure, equipment, and trained personnel. Nevertheless, there is an urgent effort in LMIC to provide COVID-19 convalescent plasma as a potentially effective therapy that can be produced locally. The Working Party on Global Blood Safety of the International Society of Blood Transfusion has published "Points to consider in the preparation and transfusion of COVID-19 convalescent plasma in low- and middle- income countries". The purpose of this commentary is to provide an urgent general frame of ethical and technical recommendations on the use of convalescent plasma to treat patients affected by the SARS-CoV-2 virus in LMIC. Key ethical, quality, and safety guidance for the selection of donors, the collection and processing of blood, and the transfusion of COVID-19 convalescent plasma should be followed. Governments should be reminded that an adequate supply of quality and safe blood components for transfusion is essential to meet the primary healthcare needs of the population. The response to the COVID-19 epidemic highlights the importance of capacity building for an organized and sustainable national blood system while steps are taken to provide appropriately collected, tested and processed COVID-19 convalescent plasma for investigational clinical use.